Kornimate/medical-research-clean huggingface dataset:
impact of photobiomodulation on pain during orthodontic treatment.

Conditions: Malocclusion; Orthodontic Treatment

Summary: the objective of this study is to determine to effect of pbm ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. we hypothesize that pbm ortho will reduced the orthodontic associated pain in the clear aligner patients. this effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.

pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. several treatment modalities have been studied to alleviate orthodontic pain which includes pharmacological, mechanical, and behavioral approach. one potential treatment is the application of photobiomodulation (pbm) therapy which is a form of light therapy. the objective of this study is to determine to effect of pbm therapy in adult patients undergoing clear aligners orthodontic treatment. this effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva. the patients will be provided with active pbm ortho device and sham pbm device (placebo, which will look similar to the active device) to use them at home for one 8 minutes application for 7 days (4 minutes per arch, upper or lower). the pain scale sheets will also be given to the patients to fill them every day for 7 days. the inflammatory protein associated with pain present in the saliva will be collected on day 1 (24 hours after clear aligner treatment start), day 4 (fourth day of treatment), and day 7 (after 1 week from the treatment start). on the last visit, the device and pain scale sheets will be collected from the patients. if successful, this device therapy will reduce the orthodontic associated pain and improve patients' compliance and cooperation.

Eligibility criteria:
inclusion criteria: * systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period. * permanent dentition, with little's irregularity index (lii) of 2 mm or greater for the upper and lower arch. * orthodontic treatment using clear aligners via non-extraction therapy. * patient is available for follow-up visits. * patient is able and willing to comply with the requirements of this trial protocol. * non-smoker with no use of chewing tobacco. * good oral hygiene. * caries free. * no sign of periodontal disease. exclusion criteria: * systemic diseases * medication use for the past 6 months; specially use of anti-inflammatory (e.g., nsaids), antiviral, antibiotics. * smoking. * active dental caries. * any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets. * sleep apnea and other airway pathologies.

Keywords: photobiomodulation clear aligners orthodontic pain
active intervention for patients with neck pain

Conditions: Neck Pain

Summary: neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. more than 80 % of individuals experience neck pain and neck associated disorders. the aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

while neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. the optimal physiotherapy intervention is currently unclear. consequently, more research in this area combining different techniques in patients with a specific clinical profile is needed. it has been previously shown that participants prefer self-care measures for the management of neck pain. the aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Eligibility criteria:
inclusion criteria: * to suffer from chronic neck pain (at least 3 months' duration) * neck pain of at least 3 on a visual analogue scale. * participants' symptoms should be at least partly related to increased nerve mechanosensitivity in the neck and upper limb confirmed by the reproduction of participants' symptoms by median nerve upper-limb neurodynamic test. exclusion criteria: * whiplash related neck pain. * previous cervical surgical intervention. * cognitive impairments which prevent them to follow instructions. * visual or acoustic limitations.
acupoint stimulation alleviates postoperative nausea and vomiting

Conditions: PONV

Summary: incidence of postoperative nausea and vomiting (ponv) could be high as 60% after liver surgery. acupoint stimulation has been proved to decrease ponv. in this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of ponv after liver surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years * scheduled for elective liver surgery under general anesthesia exclusion criteria: * body mass index less than 18 kg/m2 or higher than 30 kg/m2 * american society of anesthesiologists status higher than ⅲ * patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device * suspected or existed abuse of drug or alcohol * pregnant or breeding women * history of neurological or psychiatric disease

Keywords: transcutaneous electrical acupoint stimulation liver surgery
centralized cord blood registry to facilitate unrelated cord blood transplantation

Conditions: Leukemia; Lymphoma; Myelodysplastic Syndromes

Summary: the national marrow donor program (nmdp) has established a system for registering, matching, and tracking unrelated donor cord blood units (cbus) and transplant outcomes. study subjects are donors who enroll through collaborating cord blood banks. this study creates uniform collection, screening, testing and storage requirements for cord blood units. the purpose of standardization is to improve efficiency in the selection of cord blood units for transplantation.

the nmdp cord blood registry is organized as a network of member cord blood banks and transplant centers whose interactions are managed by the nmdp's center for cord blood. banks agree to comply with uniform collection, screening, testing and storage requirements. upon approval of membership, cord blood banks submit detailed information on each stored cbu for registration into a proprietary computer system. a transplant center, working on behalf of potential recipients, submits search requests to the nmdp and receives electronic reports detailing potentially suitable cbus. from these reports, the transplant center selects a cbu(s) for further testing, which includes at a minimum confirmation of the cbus human leukocyte antigen (hla) typing data. upon final selection of the desired cbu for transplantation, arrangements are made for timely shipment of the unit to the transplant center. following transplantation, recipient outcome data are submitted by the transplant center for addition to the study database.

Eligibility criteria:
inclusion criteria: * pregnancy exclusion criteria: -

Keywords: registry unrelated umbilical cord blood donor hematopoietic reconstitution center for cord blood bone marrow transplantation
study evaluating the ability of a nirs module to detect a urodynamic variation in humans (dettech)

Conditions: Urinary Disorders; Urinary Incontinence; Urinary Bladder Diseases

Summary: nirs technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. this hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue. in the literature, some studies concerning the use of the nirs method for the study of urodynamics exist. they seem to show a correlation between the data of the urodynamic assessment and the data obtained with the nirs method. certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase. the aim of the study is to analyze the nirs signal and find correlation with urodynamic data.

the main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.

Eligibility criteria:
inclusion criteria: * person whose urodynamic evaluation for diagnosis purposes is necessary * male or female ≥ 18 years * person affiliated with a social security scheme * ecbu / bu negative exclusion criteria: * minors * pregnant or parturient or lactating women * refusal of consent * contraindications usually provided for the realization of a urodynamic exam * sensory disturbances making the participant insensitive to pain * motor or mental disorders that prevent the participant from expressing pain * behavioral problems that make the participant excessively agitated or aggressive * irritation and / or erythema, or open sore in the area covered by the nirs * half-sitting position impossible * tattoo or stretch mark in the lower abdomen or pubic area * external cutaneous or internal scar in the area covered by the nirs * allergy to a component of the textile part of the device: polyamide, cotton, polyester, elastane, silver, other synthetic materials * simultaneous participation in another search

Keywords: urodynamic bladder detrusor urinary disorder
omitting ctv for primary tumor in ls-sclc

Conditions: SCLC, Limited Stage; Radiation Exposure; Radiotherapy Side Effect; Progression

Summary: this randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (ls-sclc). patients in the experimental group would receive radiotherapy with omission of the clinical target volume (ctv) for the primary tumor, while those in the control group would receive radiotherapy including ctv. the efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of ls-sclc. the target volume of ls-sclc may be reduced by omitting ctv without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.


Eligibility criteria:
inclusion criteria: 1. small cell lung cancer confirmed by histology or cytology; tnm stage ia-iiic (ajcc 8th edition, 2017; limited-stage) without intrapulmonary metastasis; 2. aged 18-75 years, kps score ≥ 80, ≤ 10% weight loss within the past 6 months; 3. have measurable lesions per recist 1.1 criteria; 4. have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin; 5. lung function test: fev1 ≥ 1 l (optional); 6. complete blood count: neutrophil count ≥ 1.5 x 10\^9/l, hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 10\^9/l; 7. renal function: serum creatinine ≤ 1.5 x upper limit of normal (uln); 8. liver function: ast and alt ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln; 9. fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent. exclusion criteria: 1. other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer; 2. uncontrolled heart disease or myocardial infarction within the past 6 months; 3. patients with a history of mental illness; 4. pregnant and lactating patients; 5. poorly controlled diabetes and hypertension; 6. interstitial pneumonia or active pulmonary fibrosis; 7. active infection; 8. other conditions unsuitable for enrollment (per investigator judgment).
a study of kps-0373 in patients with spinocerebellar degeneration (scd)

Conditions: Spinocerebellar Degeneration

Summary: to evaluate the efficacy and safety of kps-0373 in patients with scd.


Eligibility criteria:
inclusion criteria: * japanese scd patients with mild to moderate ataxia exclusion criteria: * patients with secondary ataxia * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: spinocerebellar degeneration thyrotropin-releasing hormone (trh) scd
study with elranatamab versus lenalidomide in patients with newly diagnosed multiple myeloma after transplant

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. in part 1 and part 2 of the study, participants in the study will either receive elranatamab (arm a and c) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm b). participation in the study will be approximately five years

elranatamab is a bispecific antibody: binding of elranatamab to cd3-expressing t-cells and bcma-expressing multiple myeloma cells causes targeted t-cell-mediated cytotoxicity.

Eligibility criteria:
inclusion criteria: * diagnosis of mm as defined according to imwg criteria (rajkumar, 2014) with measurable disease at diagnosis * part 1 patients must be mrd positive, part 2 patients can be mrd negative or mrd positive * history of induction therapy for newly diagnosed mm, followed by high dose therapy and autologous stem cell transplant. randomization must occur within 120 days from the stem cell transplant. for participants who receive consolidation therapy after asct, randomization must occur within 60 days of consolidation and within 7 months from asct. * partial response or better according to imwg criteria at the time of randomization * must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory ngs test (clonoseq assay) that is used to track mrd status. this sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant. * ecog performance status ≤1 * resolved acute effects of any prior therapy to baseline severity or ctcae grade ≤ 1 * not pregnant and willing to use contraception exclusion criteria: * plasma cell leukemia * amyloidosis, waldenström's macroglobulinemia * poems syndrome * known active cns involvement or clinical signs of myelomatous meningeal involvement * previous mm maintenance treatment * prior treatment with bcma targeted therapy * any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) hbv, hcv, and known hiv or aids-related illness * previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Keywords: bcma multiple myeloma newly diagnosed elranatamab targeted t-cell magnetismm mm7 phase 3 b-cell maturation antigen monoclonal antibody stem cell transplant autologous stem cell transplant (asct) hematologic disease minimum residual disease lenalidomide
hypermethylation of vtrna2-1 promoter in hcc outcome

Conditions: Hepatocellular Carcinoma Resectable

Summary: the clinic-pathological data were retrieved from the cancer registry database from the cancer center of chang gung memorial hospital, linkou branch. of the 92 hcc patients with partial hepatectomies enrolled. the biological specimen was studied with approval.

this study was approved by the institute review board (irb) of chang gung memorial hospital, linkou branch (irb 201801969b0). the clinic-pathological data were retrieved from the cancer registry database from the cancer center of chang gung memorial hospital, linkou branch. of the 92 hcc patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. hcc tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the central biobank of chang gung memorial hospital. the personal information was protected with decoding and registered with number.

Eligibility criteria:
inclusion criteria: subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies exclusion criteria: history of different malignant disease. subjects cannot be treated with curative surgery.

Keywords: vtrna2-1 promoter recurrence methylation
characterization of 24-hour lung function profiles of inhaled tiotropium + olodaterol fixed dose combination in patients suffering from chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of the trial is to determine the 24-hour fev1-time profile of tiotropium + olodaterol fdc, administered once daily by the respimat inhaler after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic obstructive pulmonary disease 2. relatively stable airway obstruction with a post-bronchodilator fev1\< 80% of predicted normal and a post-bronchodilator fev1/fvc \<70% 3. male or female patients, 40 years of age or older 4. smoking history of more than 10 pack years 5. ability to perform technically acceptable pulmonary function tests and maintain records 6. ability to inhale medication in a competent manner from the respimat inhaler and from a metered dose inhaler (mdi) exclusion criteria: 1. significant disease other than copd 2. clinically relevant abnormal lab values 3. history of asthma 4. diagnosis of thyrotoxicosis 5. diagnosis of paroxysmal tachycardia 6. history of myocardial infarction 7. unstable or life-threatening cardiac arrhythmia 8. hospitalization for heart failure within the past year 9. known active tuberculosis 10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. history of life-threatening pulmonary obstruction 12. history of cystic fibrosis 13. clinically evident bronchiectasis 14. history of significant alcohol or drug abuse 15. history of thoracotomy with pulmonary resection 16. oral or patch ß-adrenergics 17. oral corticosteroid medication at unstable doses 18. regular use daytime oxygen therapy for more than one hour per day 19. pulmonary rehabilitation program in the six weeks prior to the screening visit 20. investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. known hypersensitivity to ß-adrenergic drugs, bac, edta 22. pregnant or nursing women 23. women of childbearing potential not using a highly effective method of birth control 24. patients who have previously been randomised in this study or are currently participating in another study 25. patients who are unable to comply with pulmonary medication restrictions prior to randomisation
comparing simplified eeg monitoring tool with standard eeg monitoring in patients with acute neurological insult

Conditions: Acute Neurological Insult

Summary: after any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (se). these are frequently reported in patients admitted to the intensive care unit (icu) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. as such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. thus far, continuous eeg (ceeg) is the only clinical instrument that is able to detect the development of early epileptic activity. unfortunately, ceeg is not available in most icus and is labor-intensive, expensive and difficult to interpret for non-trained physicians. therefore, a more simple and prognostic accurate eeg device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. a validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified bispectral index eeg monitoring has the potential to detect epileptic activity as reliable as its gold standard, full eeg monitoring. thereby, bis eeg monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.


Eligibility criteria:
inclusion criteria: * patients (age ≥ 18 years) admitted to the icu with an acute neurological insult which will be sedated/ventilated (glasgow coma scale (gcs) ≤ 8). * ability to place bis sensors on the forehead * written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness exclusion criteria: * age \< 18 years * inability to place bis sensors on the forehead (e.g. due to frontal decompression)
harm reduction services

Conditions: Drug Use; Substance Abuse; Mental Illness

Summary: the purpose of this study is to assess whether an integrated harm reduction intervention (ihri), compared to harm reduction (hr) services as usual, will improve harm reduction service utilization among black and latinx people who use drugs (pwud).


Eligibility criteria:
inclusion criteria: * at least 18 years of age * self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using dsm-5 criteria * english or spanish speaking * able to provide informed consent. exclusion criteria: * inability to provide informed consent or participate in the study procedures as proposed in the consent * active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder) * an unwillingness to be randomized. * are prisoners

Keywords: harm reduction latinx/hispanix black/african american drug use cocaine opioids methamphetamines
evaluation of biomarkers of atopic dermatitis in pediatric patients (pedistad biomarker study)

Conditions: Dermatitis Atopic

Summary: primary objective: to explore associations between biomarkers of atopic dermatitis (ad) and: * disease state and time course of ad, * disease state and evolution of selected atopic comorbid conditions, * effectiveness of specific ad treatments.

the estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Eligibility criteria:
inclusion criteria: * participation in the obs15333 pediatric atopic dermatitis (ad) registry. * signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age. exclusion criteria: not applicable. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.